| Registry | NCT05710458 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 72 (Actual) |
| Sponsor | The University of Hong Kong (Other) |
| Conditions | Vitrectomy, Epiretinal Membrane, Macular Hole, Vitreous Hemorrhage, Retinal Detachment |
| Interventions | 25 gauge 20,000 cpm Hypervit Dual Blade, 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter (Device) |
| Dates | start 2021-07-01, primary completion 2022-10-12, completion 2022-11-30, first posted 2023-02-02, last updated 2023-02-02 |
| Locations | 1 site in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for Vitrectomy All trials for Epiretinal Membrane All trials of 25 gauge 20,000 cpm Hypervit Dual Blade All trials of 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.
In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 25 gauge 20,000 cpm Hypervit Dual Blade | Experimental | Device: 25 gauge 20,000 cpm Hypervit Dual Blade | New vitrectomy blade with higher cutting rate |
| 25 gauge 10,000 Ultravit vitrectomy cutter | Active comparator | Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter | Existing vitrectomy blade with cutting rate 10,000 cut/min |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patient over 18 years of age who are undergoing vitrectomy for the following conditions: * Macular hole * Epimacular membrane * Vitreous hemorrhage * Primary retinal detachment Exclusion Criteria: * Patient who is * unable to give proper consent * previous vitrectomy or scleral buckle surgery * cases requiring silicone oil tamponed * undergoing repeated retinal detachment surgery * undergoing surgery for tractional diabetic retinopathy
| Facility | City | Country | Status |
|---|---|---|---|
| Grantham Hospital | Hong Kong | Hong Kong |